Nearly 5 million people go to the emergency room each year in the United States for traumatic brain injury (TBI). TBI survivors may experience physical impairments and changes in emotional functioning, including personality changes or psychological symptoms. These effects can last for days or be permanent, and are often made worse by misdiagnosis.
Earlier this week, Abbott Laboratories, a global healthcare company, received FDA approval to market and sell the first rapid, handheld TBI test. Based on years of research involving neurotrauma experts from the University of Pittsburgh, the test is performed on Abbott’s i-STAT Alinity hand platform. The results are available within 15 minutes of introducing the plasma into the test cartridge.
Dr. David Okonkwo
“This is a great moment that paves the way for a quick test wherever someone needs it after a head injury. You can easily imagine this one day being used at sporting events, in nursing homes, and so many other places. I am confident that this will become a standard for the treatment and management of traumatic brain injuries, ”said Dr. David Okonkwo, director of the Center for Clinical Studies in Neurotrauma at the University of Pittsburgh and principal researcher at TRACK-TBI, an international TBI research consortium, is working with Abbott on this effort.
Okonkwo said using this device would remove the guesswork out of diagnosing TBIs and help clinicians determine the best treatment for the patient. He also found that having a blood test available could reduce the number of unnecessary CT scans by up to 40%
This test measures specific proteins in the blood after a TBI. A negative result may rule out the need for a head CT scan, a common tool used to diagnose a concussion. For those who test positive, the result complements CT scans so doctors can assess whether someone has TBI.
The TBI blood test was developed in collaboration with the US Department of Defense (DoD) and TRACK-TBI. DoD played a pivotal role in developing the test run on Abbott’s platform through the US Army Medical Materiel Development Activity of the US Army Medical Research and Development Command. The TRACK-TBI research team, led by Okonkwo and Dr. Ava Puccio of the University of Pittsburgh was the first to demonstrate how this TBI blood test can be used for the benefit of patients in clinical care.
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